Rituximab Effect on Decreasing glUcoCorticoid Exposition in PolyMyalgia Rheumatica

REDUCE PMR 1

Polymyalgia rheumatica (PMR) is prevalent among elderly. Untreated, it leads to major reduction in quality of life. Glucocorticoids are the cornerstone of treatment, but have drawbacks, warranting glucocorticoid sparing treatment. A proof of concept study on Rituximab (RTX) vs placebo showed efficacy in 48 vs 21%(p=0.049) in glucocorticoid free remission after 21 weeks (Marsman et al. 2021). Though promising, the short study duration and small sample size require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in newly diagnosed PMR patients during glucocorticoid taper.

2023-02-01

2026-01-01

2027-01-01

Recruiting

Early phase I

114

Inclusion Criteria: * Polymyalgia rheumatica diagnosis fulfilling the 2012 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria * Diagnoses less than 12 weeks ago * Glucocorticoid treatment less than 8 weeks and with dose equivalent of prednisolone ≤ 30 mg/day * Informed consent Exclusion Criteria: * treatment with systemic immunosuppressants (other than glucocorticoids) 3 months prior to inclusion; * (clinical) suspect concomitant giant cell arteritis or other rheumatic inflammatory diseases; * concomitant conditions that might significantly interfere with PMR pain or movement evaluation as judged by the investigator; * previous hypersensitivity for RTX or contra-indications to RTX.

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2023-05-24